Full Public Report - Home - NICNAS Web viewNo manufacturing, reformulation, filling or refilling of cartridges will occur in Australia. When replacing ink cartridges, the public, office

File No: STD/1250

May 2008

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)

FULL PUBLIC REPORT

FPC-200

This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Water Resources.

For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by appointment only at 334-336 Illawarra Road, Marrickville NSW 2204.

This Full Public Report is also available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at:

Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.TEL: + 61 2 8577 8800FAX + 61 2 8577 8888Website: www.nicnas.gov.au

DirectorNICNAS

TABLE OF CONTENTS

FULL PUBLIC REPORT ...............................................................................................................................................31. APPLICANT AND NOTIFICATION DETAILS.....................................................................................32. IDENTITY OF CHEMICAL.....................................................................................................................33. COMPOSITION........................................................................................................................................34. PHYSICAL AND CHEMICAL PROPERTIES........................................................................................35. INTRODUCTION AND USE INFORMATION......................................................................................46. HUMAN HEALTH IMPLICATIONS......................................................................................................5

6.1 Exposure assessment.............................................................................................................................56.1.1 Occupational exposure................................................................................................................56.1.2. Public exposure...........................................................................................................................5

6.2. Human health effects assessment.....................................................................................................6Toxicokinetics, metabolism and distribution......................................................................................................6Health effects.......................................................................................................................................................6

6.3. Human health risk characterisation..................................................................................................66.3.1. Occupational health and safety....................................................................................................66.3.2. Public health................................................................................................................................6

7. ENVIRONMENTAL IMPLICATIONS....................................................................................................77.1. Environmental Exposure & Fate Assessment..................................................................................77.1.1 Environmental Exposure..................................................................................................................77.1.2 Environmental fate...........................................................................................................................77.1.3 Predicted Environmental Concentration (PEC)...............................................................................87.2. Environmental effects assessment....................................................................................................87.2.1 Predicted No-Effect Concentration..................................................................................................87.3. Environmental risk assessment........................................................................................................9

8. CONCLUSIONS AND REGULATORY OBLIGATIONS......................................................................9Hazard classification.......................................................................................................................................9Human health risk assessment........................................................................................................................9Environmental risk assessment.......................................................................................................................9Recommendations...........................................................................................................................................9Regulatory Obligations.................................................................................................................................10

APPENDIX A: PHYSICAL AND CHEMICAL PROPERTIES ...........................................................................................11APPENDIX B: TOXICOLOGICAL INVESTIGATIONS ...................................................................................................13

B.1. Acute toxicity – oral.......................................................................................................................13B.2. Acute toxicity – dermal..................................................................................................................13B.3. Irritation – skin...............................................................................................................................14B.4. Irritation – eye................................................................................................................................14B.5. Skin sensitisation............................................................................................................................15B.6. Repeat dose toxicity.......................................................................................................................15B.7. Genotoxicity – bacteria..................................................................................................................17B.8. Genotoxicity – in vitro...................................................................................................................17B.9. Toxicokinetic assessment...............................................................................................................18

APPENDIX C: ENVIRONMENTAL FATE AND ECOTOXICOLOGICAL INVESTIGATIONS ..............................................20C.1. Environmental Fate........................................................................................................................20

C.1.1. Ready biodegradability..............................................................................................................20C.1.2. Bioaccumulation........................................................................................................................21

C.2. Ecotoxicological Investigations.....................................................................................................21C.2.1. Acute toxicity to fish.................................................................................................................21C.2.2. Acute toxicity to aquatic invertebrates......................................................................................21C.2.3. Algal growth inhibition test.......................................................................................................22C.2.4. Inhibition of microbial activity..................................................................................................23

BIBLIOGRAPHY ........................................................................................................................................................24

FULL PUBLIC REPORT

Created on 8/05/2008 3:53 PM Last Saved 12/08/2015 08:57:00AM

FPC-200

1. APPLICANT AND NOTIFICATION DETAILS

APPLICANT(S)Hewlett-Packard Australia Ltd (ABN 74 004 394 763)31-41 Joseph Street. BlackburnVictoria 3130Australia

NOTIFICATION CATEGORYLimited-small volume: Chemical other than polymer (1 tonne or less per year).

EXEMPT INFORMATION (SECTION 75 OF THE ACT)Data items and details claimed exempt from publication: Chemical Name, Other Names, CAS Number, Molecular and Structural Formulae, Molecular Weight, Spectral Data, Purity, Hazardous and Non-hazardous Impurities, Additives/Adjuvants, Identity of Manufacturer/Recipients and Import Volume.

VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)Variation to the schedule of data requirements is claimed as follows:Dissociation Constant, Bioaccumulation, Acute Inhalation Toxicity and Induction of Germ Cell Damage

PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANTNone

NOTIFICATION IN OTHER COUNTRIESJapan (2002), Belgium (2002), and USA (2004).

2. IDENTITY OF CHEMICAL

MARKETING NAME(S)FPC-200 (containing 20-30% of the notified chemical)

MOLECULAR WEIGHT>500

ANALYTICAL DATAReference NMR, IR, HPLC, UV spectra were provided. Major peaks are consistent with the structure of the notified chemical.

3. COMPOSITION

DEGREE OF PURITY>90% (manufactured as an aqueous solution containing 20-30% of the notified chemical)

4. PHYSICAL AND CHEMICAL PROPERTIES

APPEARANCE AT 20ºC AND 101.3 kPa:Pale yellow liquid (aqueous solution containing 20-30% of the notified chemical)

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The properties below were measured using aqueous solution containing 20-30% of the notified chemical. No correction was made for the concentration of the notified chemical.Property Value Data Source/JustificationFreezing Point -1.6oC MeasuredBoiling Point 99-101oC at 101.3 kPa MeasuredDensity 1100 kg/m3 at 20oC MeasuredVapour Pressure 2.2 kPa at (20oC) MeasuredWater Solubility Not determined Manufactured as an aqueous water

solution containing 20-30% of the notified chemical

Hydrolysis as a Function of pH >1 year at pH 4, 7 and 9 at 25°C MeasuredPartition Coefficient(n-octanol/water)

log Pow ≤ -6 at 20oC Estimated

Adsorption/Desorption log Koc ≤ -2.10 (worst case value) CalculatedDissociation Constant Not determined Estimated*Particle Size Not applicable The notified chemical is a liquid at

room temperature.Surface Tension 73.0 mN/m at 20oC MeasuredFlash Point Not found The notified chemical solution started

to boil at 101oC.Flammability Not flammable Estimated based on the structureAutoignition Temperature >650oC MeasuredExplosive Properties Not explosive Estimated based on the structure*The notified chemical contains a number of strong acid functionalities which are expected to remain deprotonated throughout the environmental pH range (4-9).

DISCUSSION OF PROPERTIESFor full details of tests on physical and chemical properties, please refer to Appendix A.

ReactivityThere are no known hazardous decomposition products or incompatibility with other substances. However, the notified chemical is combustible and will burn in a fire, evolving noxious fumes such as oxides of carbon, sulphur, and nitrogen.

5. INTRODUCTION AND USE INFORMATION

MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARSThe notified chemical will not be manufactured in Australia. It will be imported as a component of printing inks in pre-packed ink jet cartridges.

MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS

Year 1 2 3 4 5Tonnes <1 <1 <1 <1 <1

PORT OF ENTRYSydney

IDENTITY OF MANUFACTURER/RECIPIENTSRecipient site located in Blackburn, Victoria

TRANSPORTATION AND PACKAGINGThe notified chemical will be imported in sealed ink cartridges. Each ink jet cartridge contains approximately 18g of ink. The cartridges will be packed in sturdy cardboard boxes and normally be transported and distributed to customers by road.

FULL PUBLIC REPORT: STD/1250 Page 4 of 25

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USEThe notified chemical is used as an ingredient of water-soluble inks for use in ink-jet printers manufactured for use with plain paper. The printing inks contain <3% of the notified chemical and are used both commercially by large printing businesses and by the general public.

OPERATION DESCRIPTIONNo manufacturing, reformulation, filling or refilling of cartridges will occur in Australia. When replacing ink cartridges, the public, office staff or a trained engineer will follow replacement procedures recommended by the manufacturer. This will involve removing the seal tape and inserting the cartridge into printers. The printing process will be a fully automated and enclosed system. Service engineers may be involved in maintenance of the printer intermittently.

6. HUMAN HEALTH IMPLICATIONS

6.1 Exposure assessment

6.1.1 Occupational exposure

NUMBER AND CATEGORY OF WORKERS

Category of Worker Number Exposure Duration (hours/day)

Exposure Frequency (days/year)

Importation/Waterside workers 10 4 hours/day 70 days/yearStorage and transport 100 6 hours/day 240 days/yearOffice worker/Service technician 10000 <0.1 hour/day Intermittently

EXPOSURE DETAILSDuring transport and storage, workers are unlikely to be exposed to the notified chemical in ink except when the packaging is accidentally breached.

Office staff and service engineers may be intermittently exposed to the notified chemical (<3%) in printer ink via skin contact when replacing the spent cartridges, cleaning paper jams or during maintenance and servicing. The service engineers typically will wear gloves and receive appropriate training in servicing techniques. Dermal and possible ocular exposure could also occur when handling faulty or ruptured cartridges. Contact with paper printed with the ink containing the notified chemical is unlikely to result in dermal exposure as the chemical will be bound within the matrix of the paper and become inert, except if the paper or other substrate is handled before the ink has dried.

Workers’ exposure to the notified chemical via inhalation is unlikely due to its structure and properties (relatively high molecular weight and high water solubility). In addition, it is not expected that the notified chemical will be released during printing as the cartridge is confined within the body of the ink jet printer. Ocular exposure is also expected to be unlikely, as the ink is only released in minute amounts within the confines of the printer.

6.1.2. Public exposureThe scenarios by which the public may be exposed to the notified chemical would involve home use of printers, and are similar to those for office workers. However, it is expected that the public will be using the printer less often than workers.


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6.2. Human health effects assessment

The results from toxicological investigations conducted using an aqueous solution containing 20-30% of the notified chemical are summarised in the table below. No correction was made for the concentration of the notified chemical in these studies. Details of these studies can be found in Appendix B.

Endpoint Result andAssessment ConclusionRat, acute oral LD50 >2000 mg/kg bw

low toxicityRat, acute dermal LD50 >2000 mg/kg bw

low toxicityRabbit, skin irritation non-irritatingRabbit, eye irritation non-irritatingGuinea pig, skin sensitisation – adjuvant test no evidence of sensitisationRat, repeat dose oral toxicity – 28 days NOAEL = 1000 mg/kg bw/dayGenotoxicity – bacterial reverse mutation non mutagenicGenotoxicity – in vitro chromosomal aberration test non genotoxic

Toxicokinetics, metabolism and distributionBased on the toxicokinetic assessment (see details in Appendix B section B.9) and its structure, the notified chemical is not expected to be absorbed through the skin, gastrointestinal wall and lungs due to its high water solubility, low Pow, and relatively high molecular weight (>500).

Health effectsThe notified chemical as a 20-30% solution has a low acute oral and dermal toxicity in rats (LD50>2000 mg/kg/bw). It is not irritating to the skin and eyes of the rabbit. However, erythema, scales and/or scabs were seen in 3/5 treated females in the acute dermal study indicating a potential for skin irritation. It shows no sensitising activity in an adjuvant study in guinea pigs. The NOAEL was established to be 1000 mg/kg bw/day, which was the highest dose tested in a 28-day repeat dose oral study in rats. The solution containing the notified chemical was not mutagenic in a bacterial reverse mutation assay, and did not reveal any genotoxic potential in an in vitro test. As all toxicity studies were conducted using an aqueous water solution containing 20-30% of the notified chemical, testing of the pure chemical may have yielded different results.

Based on the available data the solution containing 20-30% of the notified chemical is not classified as hazardous under the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) (Criteria). The notified chemical cannot be classified under the Criteria.

6.3. Human health risk characterisation

6.3.1. Occupational health and safetyGiven the low hazard of the notified chemical, low likelihood of absorption via all exposure routes, low concentration of the notified chemical in the ink cartridge (<3%), and limited worker exposure, the notified chemical is not expected to pose an unacceptable risk to workers.

Regarding the potential for causing dermal irritation, this effect was found in the acute dermal study using a dose of 2000 mg/kg bw under the occlusive dressing for 24 hours. At workplaces, workers’ exposure to the notified chemical is limited, therefore, the risk of skin irritation is considered low. Nevertheless, cautions should be taken to avoid skin contact, especially for service engineers and when handling faulty and ruptured cartridges.

6.3.2. Public healthBased on the similar use and exposure pattern to the workers, plus potentially less frequent exposure to the public than workers, the notified chemical is not expected to pose an unacceptable risk to the general public.


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7. ENVIRONMENTAL IMPLICATIONS

7.1. Environmental Exposure & Fate Assessment

7.1.1 Environmental Exposure

RELEASE OF CHEMICAL AT SITEPrinter ink is imported in ready-to-use cartridges (containing <3% notified chemical). No release is expected as manufacturing and reformulation of the ink containing the notified chemical will not take place in Australia. Environmental release of the notified chemical is unlikely during importation, storage, transportation and spillage during a transport accident is the most likely reason for environmental release. Individual container capacity, container and packaging specifications would limit the extent of release.

RELEASE OF CHEMICAL FROM USERelease of the ink solution to the environment is not expected under normal use as ink cartridges are designed to prevent leakage. Spent cartridges will be replaced by service technicians, office workers or the public. However, if leakage or spillage does occur, the ink will be contained with absorbent material, which is likely to be disposed of in a landfill site.

Ultimately, all the notified chemical will be released to the environment. Paper towhich the notified chemical will be bound will eventually be buried in landfill or incinerated, or the chemical may be released in effluent from de-inking processes. Residues left in empty cartridges will most likely be disposed of to landfill.

Recycling of treated paper may result in the release of a proportion of the notified chemical to the aquatic compartment.

RELEASE OF CHEMICAL FROM DISPOSALThe total import volume of the notified chemical will ultimately be disposed as normal office/domestic waste that will end up in either landfill or be incinerated. Some waste paper printed with the ink may be disposed of directly to landfill with the notified chemical bound to the paper. Some will enter the paper recycling process. Used cartridges may be sent to recycling and disposal centres. The cartridges will be broken down into component parts for recycling. Residual ink (<3% of the notified chemical) left in the empty cartridges will be separated from the cartridges and incinerated during the recycling of the cartridges.

Recycling of treated paper may result in the release of a proportion of the notified chemical to the aquatic compartment. Waste paper is repulped using a variety of chemical treatments, which result in fibre separation and ink detachment from the fibres. The waste is expected to go to trade waste sewers. Approximately 50% of the ink printed on paper will enter paper recycling of which, based on its high water solubility, only a small proportion of the notified chemical is expected to be recovered during recycling. While most may partition to water, due to the low percentage of the notified chemical in these inks and the widespread use, release to the aquatic compartment from any given recycling plant will still be low based on worst case assumptions. Any chemical absorbed to sludge during recycling process will be disposed of to landfill.

The notified chemical that is incinerated is expected to thermally decompose to form predominantly simple organic compounds and various salts. Similarly, the notified chemical that is disposed of to landfill should eventually degrade.

7.1.2 Environmental fate

A single ready biodegradability test was submitted, which showed the notified chemical achieved 10% biodegradation after 28 days. Therefore, the notified chemical cannot be considered to be readily biodegradable according to the OECD criteria. For the details of the environmental fate studies please refer to Appendix C.


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7.1.3 Predicted Environmental Concentration (PEC)

Manufacture, reformulation and packaging into end-use containers occurs overseas, and release is not expected. After use, printed-paper may be disposed of by incineration, to landfill or be recycled. The notified chemical disposed of to landfill, may be mobile, however, the low proposed annual import volume, and diffuse release throughout Australia will mitigate any potential exposure while the notified chemical slowly degrades.

In Australia, approximately 50% of printed-paper is recycled. The following Predicted Environmental Concentration calculation assumes this 50% recycling, and as a worst case scenario assumes no recovery within STPs.

Predicted Environmental Concentration (PEC) for the Aquatic CompartmentTotal Annual Import/Manufactured Volume 1,000 kg/yearProportion expected to be released to sewer 50%Annual quantity of chemical released to sewer 500 kg/yearDays per year where release occurs 365 days/yearDaily chemical release: 1.37 kg/dayWater use 200.0 L/person/dayPopulation of Australia (Millions) 21.161 millionRemoval within STP 0%Daily effluent production: 4,232 MLDilution Factor - River 1.0Dilution Factor - Ocean 10.0PEC - River: 0.32 μg/LPEC - Ocean: 0.03 μg/L

STP effluent re-use for irrigation occurs throughout Australia. The agricultural irrigation application rate is assumed to be 1000 L/m2/year (10 ML/ha/year). The notified chemical in this volume is assumed to infiltrate and accumulate in the top 10 cm of soil (density 1300 kg/m 3). Using these assumptions, irrigation with a concentration of 0.324 g/L may potentially result in a soil concentration of approximately 2.490 X 10-3 mg/kg. Assuming accumulation of the notified chemical in soil for 5 and 10 years under repeated irrigation, the concentration of notified chemical in the applied soil in 5 and 10 years may be approximately 1.245 X 10-2 mg/kg and 2.490 X 10-2 mg/kg, respectively.

7.2. Environmental effects assessment

The results from ecotoxicological investigations conducted using an aqueous solution containing 20-30% of the notified chemical are summarised in the table below. Details of these studies can be found in Appendix C.

Endpoint Result Assessment ConclusionFish Toxicity LC50 >100 mg/L Not HarmfulDaphnia Toxicity EiC50 >100 mg/L Not HarmfulAlgal Toxicity ErC50 >100 mg/L Not HarmfulInhibition of Bacterial Respiration EiC50 >100 mg/L Not Harmful

7.2.1 Predicted No-Effect Concentration

Aquatic ecotoxicity data were provided for three trophic levels. The following Predicted No-Effect Concentration has been calculated using an assessment factor of 100.

Predicted No-Effect Concentration (PNEC) for the Aquatic CompartmentEC50 (Alga) >100 mg/LAssessment Factor 100PNEC >1,000 μg/L


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7.3. Environmental risk assessmentBased on the above PEC and PNEC values, the following Risk Quotient (Q) has been calculated.

Risk Assessment PEC μg/L PNEC μg/L QQ - River: 0.32 >1000 <0.00032Q - Ocean: 0.03 >1000 <0.00003

This indicates that the current import volume and use pattern is not expected to pose an unacceptable risk to the aquatic environment.

8. CONCLUSIONS AND REGULATORY OBLIGATIONS

Hazard classificationBased on the available data the solution containing 20-30% of the notified chemical is not classified as hazardous under the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). The notified chemical cannot be classified under the Criteria.

Human health risk assessmentUnder the conditions of the occupational settings and public uses described, the notified chemical is not considered to pose a risk to the workers and the general public.

Environmental risk assessmentOn the basis of the PEC/PNEC ratio, the notified chemical is not considered to pose a risk to the environment from its reported use pattern.

Recommendations

CONTROL MEASURESOccupational Health and Safety

Employers should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical in the imported ink cartridges: Use of appropriate PPE by printer service technicians to avoid dermal exposure.

Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.

A copy of the MSDS should be easily accessible to employees.

If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation.

Environment

The notified chemical should be disposed of to landfill in accordance with State/Territory waste disposal regulations.

Spills/release of the notified chemical should be contained with an absorbent, inert material (soil, sand, sawdust, vermiculite) and collected in sealable, labelled containers for disposal.


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Regulatory Obligations

Secondary NotificationThis risk assessment is based on the information available at the time of notification. The Director may call for the reassessment of the chemical under secondary notification provisions based on changes in certain circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the notifier, as well as any other importer or manufacturer of the notified chemical, have post-assessment regulatory obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the notified chemical is listed on the Australian Inventory of Chemical Substances (AICS).

Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, other importer or manufacturer:

(1) Under Section 64(1) of the Act; if the notified chemical is introduced at a concentration >30%.

or

(2) Under Section 64(2) of the Act; if the function or use of the chemical has changed from ink component, or is likely to change

significantly; the amount of chemical being introduced has increased from one tonne, or is likely to increase,

significantly; if the chemical has begun to be manufactured in Australia; additional information has become available to the person as to an adverse effect of the chemical

on occupational health and safety, public health, or the environment.

The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required.

No additional secondary notification conditions are stipulated.

Material Safety Data SheetThe MSDS of the product containing the notified chemical provided by the notifier was reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant.


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APPENDIX A: PHYSICAL AND CHEMICAL PROPERTIES All tests below were conducted using an aqueous solution containing 20-30% of the notified chemical. No correction was made for the concentration of the notified chemical.

Freezing Point -1.6oC

METHOD OECD TG 102 Melting Point/Melting Range.EC Directive 92/69/EEC A.1 Melting/Freezing Temperature.

Remarks At a temperature of -0.6oC and -0.4oC, the notified chemical became cloudy and started to freeze. At a temperature of -1.6oC, it was completely solid.

TEST FACILITY Notox (2002b)

Boiling Point 99-101oC at 101.3 kPa

METHOD OECD TG 103 Boiling Point.EC Directive 92/69/EEC A.2 Boiling Temperature.

Remarks The test was performed using a differential scanning calorimeter. The boiling residue reacts or decomposes at >275oC.

TEST FACILITY Notox (2002c)

Density 1100 kg/m3 at 20 ± 0.5oC

METHOD OECD TG 109 Density of Liquids and Solids.EC Directive 92/69/EEC A.3 Relative Density.

Remarks The test was performed using a glass pycnometer at a nominal volume of 10mL.TEST FACILITY Notox (2002d)

Vapour Pressure 2.2 kPa at 20oC

METHOD OECD TG 104 Vapour Pressure.EC Directive 92/69/EEC A.4 Vapour Pressure.

Remarks The vapour pressure at 20oC was extrapolated from the vapour pressure curve using static vapour pressure measurements made with a capacitance manometer. They are 5.9 kPa at 37.02oC, 4.3 kPa at 31.52oC, and 3.1 kPa at 25.62oC.

TEST FACILITY Notox (2002e)

Hydrolysis as a Function of pH Hydrolytically stable

METHOD OECD TG 111 Hydrolysis as a Function of pH.EC Directive 92/69/EEC C.7 Degradation: Abiotic Degradation: Hydrolysis as a

Function of pH.

pH T (C) t½ <hours or days>4 25 >1 year7 25 >1 year9 25 >1 year

Remarks Less than 10% hydrolysis (HPLC) was observed at 50oC after 5 days in all buffer solutions. Hence, the notified chemical is hydrolytically stable.

TEST FACILITY Notox (2002g)

Partition Coefficient (n-octanol/water)

log Pow ≤ -6 at 20oC

METHOD OECD TG 117 Partition Coefficient (n-octanol/water).EC Directive 92/69/EEC A.8 Partition Coefficient.

Remarks The Estimation method was used.The solubility of the notified chemical at 20oC was ≤0.6x10-3 g/L in n-octanol and


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>1000 g/L in water. The partition coefficient (n-octanol/water), Pow, calculated as a quotient of the n-octanol solubility and water solubility of the notified chemical, is ≤6x10-7 (log Pow ≤ -6).

TEST FACILITY Notox (2002h)

Adsorption/Desorption log Koc ≤ -2.10 (worst case value)

METHOD Expert Statement – calculated using the QSAR method described in the Technical Guidance Document on Risk Assessment (European Commission, 1996).

Remarks For calculation of adsorption/desorption of the notified chemical, several chemical classes such as non hydrophobics (I), alcohols (II) and triazines (III) having different QSARs and a log Pow ≤ -6.0 for the notified chemical were used:

(I) log Koc = 0.52 log Pow + 1.02 ≤ -2.10(II) log Koc = 0.39 log Pow + 0.50 ≤ -1.84(III) log Koc = 0.30 log Pow + 1.50 ≤ -0.30log Koc ≤ -2.10 (worst case value ie lowest adsorption to soil, based on the log P ow

of the notified chemical). In conclusion, the different QSARs give different outcomes of the log Koc. For risk assessment purposes, the worst case calculated value should be used, in view of all uncertainties using QSAR.

TEST FACILITY Notox (2002i)

Dissociation Constant Not determined

Remarks The notified chemical contains a number of strong acid functionalities which are expected to remain deprotonated throughout the environmental pH range (4-9).

Surface Tension 73.0 mN/m at 20 ± 0.5oC

METHOD OECD TG 115 Surface Tension of Aqueous Solutions.EC Directive 92/69/EEC A.5 Surface Tension.

Remarks Concentration: 1.199 g/L. A ring tesnsiometer was used. Based on the criteria as outlined in the guideline, the notified chemical should not be regarded as a surface active material.

TEST FACILITY Notox (2002j)

Flash Point No flash point found

METHOD EC Directive 92/69/EEC A.9 Flash Point.Remarks The test was performed using a Pensky-Martens closed cup apparatus. The notified

chemical solution started to boil at 101oC.TEST FACILITY Notox (2002k)

Autoignition Temperature >650oC

METHOD 92/69/EEC A.15 Auto-Ignition Temperature (Liquids and Gases).Remarks No auto-ignition temperature was found at a temperature range of 200-650oC.TEST FACILITY Notox (2002m)

Explosive Properties Not explosive

METHOD EC Directive 92/69/EEC A.14 Explosive Properties.Remarks Test was not performed, as the notified chemical does not contain any chemically

unstable or highly energetic groups that might lead to an explosion.TEST FACILITY Notox (2002n)


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APPENDIX B: TOXICOLOGICAL INVESTIGATIONS

All tests below were conducted using an aqueous solution containing 20-30% of the notified chemical. No correction was made for the concentration of the notified chemical.

B.1. Acute toxicity – oral

TEST SUBSTANCE Notified chemical

METHOD OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method.EC Directive 92/69/EEC B.1tris Acute Oral Toxicity – Acute Toxic Class

Method.Species/Strain Rat/Wistar Crl:(WI) BRVehicle Undiluted as suppliedRemarks - Method No significant protocol deviations.

RESULTS

Group Number and Sexof Animals

Dosemg/kg bw

Mortality

I 3 females 2000 0/3II 3 males 2000 0/3

LD50 >2000 mg/kg bwSigns of Toxicity Lethargy was noted among all females and in one male on day 1. The

mean body weight gain by the animals over the study period was considered to be normal.

Effects in Organs No abnormalities were found at macroscopic post mortem examination of the animals.

CONCLUSION The notified chemical is of low toxicity via the oral route.

TEST FACILITY Notox (2002o)

B.2. Acute toxicity – dermal


METHOD OECD TG 402 Acute Dermal Toxicity.EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal).

Species/Strain Rat/Wistar Crl:(WI) BRVehicle Undiluted as suppliedType of dressing Occlusive dressing for females only. Semi-occlusive for males.Exposure duration 24 hoursRemarks - Method No significant protocol deviations.

RESULTS


Dosemg/kg bw

Mortality

I 5 females 2000 0/3II 5 males 2000 0/3

LD50 >2000 mg/kg bwSigns of Toxicity - Local Erythema, scales and/or scabs were seen on the treated skin area of three

out of five females during the observation period (15 days).Signs of Toxicity - Systemic The males were calm on day 1. No signs of systemic toxicity were noted


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in the females. The changes noted in body weight gain in all test animals were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.

Effects in Organs No abnormalities were found at macroscopic post mortem examination of the animals.

CONCLUSION The notified chemical is of low toxicity via the dermal route.

TEST FACILITY Notox (2002p)

B.3. Irritation – skin


METHOD OECD TG 404 Acute Dermal Irritation/Corrosion.EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).

Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3 malesVehicle Undiluted as suppliedObservation Period 72 hoursType of Dressing Semi-occlusiveRemarks – Method No significant protocol deviations.

RESULTSRemarks - Results There was no evidence of dermal corrosion or irritation caused by 4 h

exposure to the notified chemical. No staining of the treated skin was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

CONCLUSION The notified chemical is non-irritating to the skin.

TEST FACILITY Notox (2002q)

B.4. Irritation – eye


METHOD OECD TG 405 Acute Eye Irritation/Corrosion.EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation).

Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3 malesObservation Period 72 hoursRemarks - Method No significant protocol deviations.

RESULTSRemarks - Results Instillation of 0.1 mL of the notified chemical into one eye of each of

three rabbits did not result in irritation of the conjunctivae in any of the animals. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 h after instillation of the notified chemical revealed no corneal epithelial damage in any of the animals. There was no evidence of ocular corrosion. No staining of (peri) ocular tissues by the notified chemical was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

CONCLUSION The notified chemical is non-irritating to the eye.

TEST FACILITY Notox (2002r)


May 2008 NICNAS

B.5. Skin sensitisation


METHOD OECD TG 406 Skin Sensitisation – Maximisation Test.EC Directive 96/54/EC B.6 Skin Sensitisation – Maximisation Test.

Species/Strain Guinea pig/Dunkin HartleyPRELIMINARY STUDY Maximum Non-irritating Concentration:

intradermal: <10% test solutiontopical: 100% test solution

MAIN STUDYNumber of Animals Test Group: 10 females Control Group: 5 femalesINDUCTION PHASE Induction Concentration:

intradermal: 100% test solution at 1:1 mixture with Freund’s Complete Adjuvant or vehicle (Milli-U water)

topical: 100% test solutionSigns of Irritation During induction, erythema (scores of 1 and 2) was noted in both test and

control animals (6/10 vs 3/5 for intradermal; 4/10 vs 3/5 for epidermal). The reactions noted after the epidermal induction were considered to be enhanced by the SDS (10% sodium-dodecyl-sulfate) treatment.

CHALLENGE PHASE1st challenge topical: 100% test solutionRemarks - Method No significant protocol deviations.

RESULTSRemarks - Results No skin reactions were evident after the challenge exposure in the test and

control animals. No mortality occurred and no symptoms of systemic toxicity were observed. A separate positive control study with alpha-hexylcinnamic aldehyde confirmed the sensitivity of the test system.

CONCLUSION There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test.

TEST FACILITY Notox (2002s)

B.6. Repeat dose toxicity


METHOD OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents.EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral).

Species/Strain Rat/Wistar Crl:(WI) BRRoute of Administration Oral – gavageExposure Information Total exposure days: 28 days

Dose regimen: 7 days per weekPost-exposure observation period: 0 day

Vehicle Milli-U waterRemarks - Method The following protocol deviations were noted:

1) Deviations from the maximum level of temperature occurred (with a maximum of 0.5°C);2) On day 7, the maximum time between the earliest and latest dose was exceeded by approximately 45 minutes;3) Cervix and vagina were examined microscopically from all control and high dose females.These deviations were considered not to have affected study integrity.


May 2008 NICNAS

RESULTS


Dose*mg/kg bw/day

Mortality

control 5 per sex 0 0/10low dose 5 per sex 50 0/10mid dose 5 per sex 150 0/10high dose 5 per sex 1000 0/10

*No correction was made for the purity of the notified chemical.

Mortality and Time to DeathNo mortality occurred during the study period.

Clinical ObservationsThere were no clinical signs of toxicity or behavioural changes over the 28-day observation period that were considered to be related to treatment.

Incidental findings that were noted included alopecia and/or brown staining among females of the low and high dose groups. These findings are commonly noted in rats of this age and strain which are housed and treated under the conditions in this study. At the incidence observed, these were considered to be of no toxicological significance. No clinical signs were noted among the other animals.

No changes were observed in hearing ability, pupillary reflex, static righting reflex and grip strength in the animals treated with the notified chemical, when compared to control animals. The variation in motor activity did not indicate a relationship with treatment.

Body weight and body weight gain of treated animals remained in the same range as controls over the 4-week study period.

Food consumption before or after allowance for body weight between treated and control animals was similar.

Laboratory Findings – Clinical Chemistry, Haematology, UrinalysisHaematological parameters of treated rats were considered not to have been affected by treatment. Statistically significant lower white blood cell count of animals receiving 50 mg/kg/day were considered to have arisen by chance and not to represent a change of biological significance.

There were no differences noted in clinical biochemistry between control and treated rats that were considered to be related to treatment.

The increased mean potassium value of high dose females was within the normal range and was not supported by other findings. Values in males of the intermediate dose groups achieving a level of statistical significance when compared to controls did so in the absence of a dose related response. Also, values were similar to comparable studies. Therefore, these changes were considered to be of no toxicological significance.

Effects in OrgansOrgan weights and organ:body weight ratios of treated animals were considered to be similar to those of control animals. Statistically significant changes between relative thymus weights of males of the 150 mg/kg/day group and control males were considered not to be a sign of toxicity.

Macroscopic observations at necropsy did not reveal any alterations that were considered to have arisen as a result of treatment. Incidental findings among control and treated animals included red discolouration of the lungs, thymus or mandibular lymph node, an accentuated lobular pattern or diaphragmatic hernia of the liver, pelvic dilation of the kidneys, nodules on the epididymides and fluid in the uterus. These findings are occasionally seen among rats used in these types of studies and in the absence of correlated microscopic findings and/or a dose-related response, therefore, they were considered changes of no toxicological significance.

All microscopic findings were within the range of background pathology encountered in Wistar rats of this age and strain and occurred at similar incidences and severity in both control and treated rats.


May 2008 NICNAS

Remarks – ResultsThere were no changes at determination of clinical appearance, performance of functional observations, body weight and food consumption measurements, or alterations during haematological investigations, macroscopic examination, organ weight determination and microscopic examination that were considered to be an effect of treatment.

CONCLUSIONThe No Observed Adverse Effect Level (NOAEL) was established as 1000 mg/kg bw/day, which is the highest dose tested in this study.

TEST FACILITY Notox (2002t)

B.7. Genotoxicity – bacteria


METHOD OECD TG 471 Bacterial Reverse Mutation Test.EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test

using Bacteria.Plate incorporation procedure

Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100E. coli: WP2uvrA

Metabolic Activation System S9 fraction from Aroclor 1254 induced rat liverConcentration Range inMain Test

a) With metabolic activation:3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plateb) Without metabolic activation:3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate

Vehicle Milli-Q-waterRemarks – Method Two independent tests were conducted, each in triplicate.

RESULTS

Metabolic Activation

Test Substance Concentration (µg/plate) Resulting in:Cytotoxicity in

Preliminary TestCytotoxicity in

Main TestPrecipitation Genotoxic Effect

AbsentTest 1 >5000

(TA100 & WP2uvrA)

>5000(other strains)

>5000 Negative

Test 2 -- >5000(all strains)

>5000 Negative

PresentTest 1 >5000

(TA100 & WP2uvrA)

>5000(other strains)

>5000 Negative

Test 2 -- >5000(all strains)

>5000 Negative

Remarks - Results All other bacterial strains showed negative responses over the entire dose range, ie no dose-related, two-fold increase in the number of revertants in two independently repeated experiments. The vehicle and positive controls responded appropriately.

CONCLUSION The notified chemical was not mutagenic to bacteria under the conditions of the test.

TEST FACILITY Notox (2002u)


May 2008 NICNAS

B.8. Genotoxicity – in vitro


METHOD OECD TG 473 In vitro Mammalian Chromosome Aberration Test.EC Directive 2000/32/EC B.10 Mutagenicity – In vitro Mammalian Chromosome Aberration Test.

Cell Type/Cell Line Peripheral human lymphocytesMetabolic Activation System S9 fraction from Aroclor 1254 induced rat liverVehicle F10 medium buggered with 20mM HEPESRemarks - Method Two independent tests were conducted, each in triplicate.


Test Substance Concentration (μg/mL) Exposure Period

HarvestTime

AbsentTest 1 1000*, 3330*, 5000* 3 h 24 hTest 2 1000*, 3330*, 5000* 24 h and 48 h 24 h and 48 hPresentTest 1 1000*, 3330*, 5000* 3 h 24 hTest 2 1000*, 3330*, 5000* 3 h 48 h*Cultures selected for metaphase analysis.

RESULTS


Test Substance Concentration (µg/mL) Resulting in:Cytotoxicity in

Preliminary TestCytotoxicity in

Main TestPrecipitation Genotoxic Effect

AbsentTest 1 >5000 >5000 >5000 NegativeTest 2 -- >5000 >5000 NegativePresentTest 1 >5000 >5000 >5000 NegativeTest 2 -- >5000 >5000 Negative

Remarks - Results The number of cells with chromosomal aberrations found in the vehicle control cultures were within the laboratory historical control data range. Both in the presence and absence of S9-mix, the notified chemical did not induce a statistically significant or biologically relevant increase in the number of cells with chromosomal aberrations in two independent experiments. In test 1, several polyploid cells were observed, but since these cells were also observed in cultures treated with vehicle, and since the number of polyploid cells did not increase with dose, this observation was regarded not biologically relevant. The vehicle and positive controls responded appropriately.

CONCLUSION The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test.

TEST FACILITY Notox (2002v)

B.9. Toxicokinetic assessment


ASSESSMENT


May 2008 NICNAS

The acute oral and dermal toxicity of a solution containing 20-30% of the notified chemical is low (LD50>2000 mg/kg bw). The 28-day toxicity study also revealed that it has a relatively low toxicity, with a NOAEL of 1000 mg/kg/day. Therefore, an extensive toxicokinetic assessment is considered of limited value.

The notified chemical is soluble in water, caused by the presence of the strongly polar sulfonic acid groups. The strong polarity of these groups makes it very unlikely that this compound easily passes the gastrointestinal wall. Therefore, it is to be expected that the oral bioavailability, and thus the systemic exposure, of the notified chemical will be low.

In the case absorption of the chemical occurs, extensive hydroxylation of the aromatic rings is anticipated, followed by a rapid sulphation or glucuronidation. Another possibility is that dealkylation at the secondary amines occurs. The resulting metabolites, as well as the parent compound will be extensively excreted via urine or bile.

The notified chemical will show a low volume of distribution equalling extracellular body water (approximately 0.7 L per kg bw). Accumulation in fatty tissues is not anticipated. The plasma protein binding is expected to be low.

Since the bioavailability of dermally applied compounds can be assumed to be zero for substances with a log Pow below -1 and over 5 or a relative molecular mass over 700, it is not to be expected that the notified chemical will be absorbed through the skin.

Based on the expected kinetic behaviour in the body, as described above, the notified chemical will hardly be absorbed after oral administration, because of the presence of strongly polar groups in the molecule. If absorption occurs, the notified chemical will be extensively metabolised in the liver. Therefore, accumulation in the body during prolonged exposure will be very low.

This is supported by the low systemic toxicity observed in both the acute and subacute toxicity studies.

TEST FACILITY Notox (2002w)


May 2008 NICNAS

APPENDIX C: ENVIRONMENTAL FATE AND ECOTOXICOLOGICAL INVESTIGATIONS

All tests below were conducted using an aqueous solution containing 20-30% of the notified chemical. No correction was made for the concentration of the notified chemical.

C.1. Environmental Fate

C.1.1. Ready biodegradability


METHOD OECD TG 301 B Ready Biodegradability: CO2 Evolution Test.Directive 92/69/EEC, C.4/C.4C

Inoculum Activated sludge freshly obtained from a municipal sewage treatment plant “Waterschap de Maaskant” ‘s Hertogenbosch, The Netherlands.The sludge was kept under continuous aeration until further treatment.

Before use, the sludge was allowed to settle for 30-90 minutes and the liquid decanted for use as inoculum at the rate of 10mL/L of mineral medium.

Exposure Period 28 daysAuxiliary Solvent NoneAnalytical Monitoring Carbon dioxide produced during the test was reacted with barium

hydroxide in a gas scrubbing bottle and precipitated as barium carbonate. The amount of carbon dioxide was determined by titrating the remaining barium hydroxide with 0.05M standardised hydrochloric acid solution.

Remarks - Method No significant deviations were reported.

RESULTS

Test substance Sodium acetateDay % Degradation Day % Degradation

2 1 2 65 1 5 437 3 7 629 5 9 7514 5 14 8819 6 19 9423 6 23 9827 10 27 10029 10 29 100

Remarks - Results The relative degradation values calculated from the measurements performed during the test period revealed 16% degradation of the test substance in test bottle A and no significant degradation in test bottle B (5%). The mean degradation in both bottles was 10%. Hence, the test material did not meet the criteria for ready biodegradability.

The reference substance passed the criterion and in the toxicity control the test substance was found to be not inhibitory on microbial activity.

CONCLUSION The test substance cannot be considered to be readily biodegradable according to the OECD criteria

TEST FACILITY Notox (2002aa)


May 2008 NICNAS

C.1.2. BioaccumulationNo bioaccumulation data were provided. However, the bioaccumulation potential of the notified chemical is low due to its high water solubility and the low lipid solubility and log Pow.

C.2. Ecotoxicological Investigations

C.2.1. Acute toxicity to fish


METHOD OECD TG 203 Fish, Acute Toxicity Test - Static.EC Directive 92/69/EEC C.1 Acute Toxicity for Fish - Static.

Species Carp (Cyprinus carpio)Exposure Period 96 hoursAuxiliary Solvent NoneWater Hardness 250 mg CaCO3/LAnalytical Monitoring HPLCRemarks – Method Analysis of the samples taken during the range-finding study showed that

the measured concentration of the notified chemical was in agreement with nominal at the start of the test (90%) and did not decrease by more than 20% during the 96-hour test period (93% after 24 hours of exposure and 99% after 96 hours of exposure).

RESULTS

Concentration mg/L Number of Fish MortalityNominal Actual 4 h 24 h 48 h 72 h 96 h

0 0 7 0 0 0 0 0100 100 7 0 0 0 0 0

LC50 >100 mg/L at 96 hours.NOEC 100 mg/L at 96 hours.Remarks – Results Under the conditions of the study, the notified chemical did not induce

lethal effects in carp at 100 mg/L after 96 hours of exposure. Thus, the LC50 96 h for Carp exposed to the notified chemical is >100 mg/L. At 24 h all fish were observed swimming at the bottom of the tank in the test vessel containing 100 mg/L. This was not observed at later times.

CONCLUSION The notified chemical is very slightly toxic to Cyprinus carpio (carp) according to Mensink et al. (1995).

TEST FACILITY Notox (2002bb)

C.2.2. Acute toxicity to aquatic invertebrates


METHOD OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction Test - Static.

EC Directive 92/69/EEC C.2 Acute Toxicity for Daphnia - Static.Species Daphnia magnaExposure Period 48 hoursWater Hardness 250 mg CaCO3/LAnalytical Monitoring HPLCRemarks – Method Analysis of the samples taken during the pre-test showed that the

measured concentration of all samples taken at the start of the test were between 98 and 102 mg/L. During the exposure period the measured concentration of the samples taken from the vessels which


May 2008 NICNAS

were kept in the dark remained constant. Therefore the study was continued with a range-finding test and a limit test, which were both performed in the dark. All test solutions were clear and colourless. Oxygen content (8.7-9.2 mg O2/L), pH (7.9-8.2) and temperature (19.8-20.7C) were satisfactorily maintained.

RESULTS

Concentration mg/L Number of D. magna Number ImmobilisedNominal Actual 24 h 48 h*

0 10 0 03.5 10 0 0 (1)10 10 0 0 (1)35 10 0 0100 10 0 0 (1)

* Between brackets: number of daphnids observed trapped at the surface of the test solutions. These daphnids were reimmersed in the respective solutions before scoring of mobility.

EC50 >100 mg/L at 48 hoursNOEC 100 mg/L at 48 hoursRemarks – Results The data show no immobility in the blank-control and no immobility in

the test concentrations after 48 hours of exposure.

CONCLUSION The notified chemical is very slightly toxic to Daphnia magna according to Mensink et al. (1995).

TEST FACILITY Notox (2002cc)

C.2.3. Algal growth inhibition test


METHOD OECD TG 201 Alga, Growth Inhibition Test.EC Directive 92/69/EEC C.3 Algal Inhibition Test.ISO Standard 8692, 1st Edition, 15 November 1989

Species Fresh water Algae Selenastrum capricornutumExposure Period 72 hoursConcentration RangeNominal

0, 0.1, 1.0, 10 and 100 mg/L

Concentration RangeActual

Not measured.

Auxiliary Solvent Not applicableWater Hardness 24 mg CaCO3/LAnalytical Monitoring HPLC

Remarks – Method No significant deviations from the test protocol were reported.

RESULTS

Biomass GrowthEbC50 NOEC ErC50 NOEC

mg/L at 72 h mg/L mg/L at 72 h mg/L>100 100 >100 100

Remarks – Results The EC50 values could not be estimated for both growth inhibition EbC50 (0-72h) and growth rate reduction ErC50 (0-72h) as both were above a loading of 100mg/L.

CONCLUSION Under the conditions of the study with Selenastrum capricornutum, no inhibition of cell growth or reduction of growth rate was recorded at 100 mg/L of the notified chemical.


May 2008 NICNAS

TEST FACILITY Notox (2002dd)

C.2.4. Inhibition of microbial activity


METHOD OECD TG 209 Activated Sludge, Respiration Inhibition Test.EC Directive 67/548 amended 1987 (87/302) Part C, Publication No

L133, adopted May 30, 1988.Inoculum Municipal sewage treatment plant “Waterschap de Maaskant” ‘s

Hertogenbosch, The Netherlands.Exposure Period 0.5 hoursConcentration RangeNominal

100 mg/L

Remarks – Method No significant protocol deviations were reported.

RESULTSIC50 >100 mg/LNOEC 100 mg/LRemarks – Results No significant inhibition of respiration rate of the sludge was recorded at

100 mg/L of the notified chemical. A duplicate measurement confirmed the result. The EC50 of the reference substance was 11 mg/L, and thus the test was considered valid.

CONCLUSION Under the conditions of the test, the notified chemical was not toxic to waste water (activated sludge) bacteria at a concentration of 100 mg/L

TEST FACILITY Notox (2002ee)


May 2008 NICNAS

BIBLIOGRAPHY Mensink BJWG, Montforts M, Wijkhuizen-Maslankiewicz L, Tibosch H and Linders JBHJ (1995) Manual for

summarising and evaluating the environmental aspects of pesticides. National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands. Report No. 679101022.

NOHSC (2004) Approved Criteria for Classifying Hazardous Substances, 3 rd edition [NOHSC:1008(2004)]. National Occupational Health and Safety Commission, Canberra, AusInfo.

Notox (2002a) Analytical data for FPC-200. Project no. 340807. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002b) Determination of the freezing temperature of FPC-200. Project no. 340548. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002c) Determination of the boiling temperature of FPC-200. Project no. 346343. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002d) Determination of the density of FPC-200. Project no. 340559. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002e) Determination of the vapour pressure of FPC-200. Project no. 340561. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002f) Determination of the water solubility of FPC-200. Project no. 340583. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002g) Determination of the hydrolysis of FPC-200 as a function of pH. Project no. 351833. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002h) Determination of the partition coefficient (n-octanol/water) of FPC-200. Project no. 340594. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002i) Adsorption/Desorption of FPC-200. Project no. 340651. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002j) Determination of the surface tension of an aqueous solution of FPC-200. Project no. 340572. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002k) Determination of the flash point of FPC-200. Project no. 340605. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002l) Determination of the flammability (contact with water) of FPC-200. Project no. 340616. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002m) Determination of the auto-ignition temperature of FPC-200. Project no. 340649. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002n) Statement of the explosive properties of FPC-200. Project no. 340638. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002o) Assessment of acute oral toxicity with FPC-200 in the rat. Project no. 340662. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002p) Assessment of acute dermal toxicity with FPC-200 in the rat. Project no. 340673. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002q) Primary skin irritation/corrosion study with FPC-200 in the rabbit. Project no. 340684. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002r) Acute eye irritation/corrosion study with FPC-200 in the rabbit. Project no. 340694. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).


May 2008 NICNAS

Notox (2002s) Assessment of contact hypersensitivity to FPC-200 in the albino guinea pig. Project no. 340706. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002t) Subacute 28-day oral toxicity with FPC-200 in the rabbit. Project no. 340728. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002u) Evaluation of the mutagenic activity of FPC-200 in the S. typhimurium: and E. coli mutation assay. Project no. 340739. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002v) Evaluation of the ability of FPC-200 to induce chromosome aberration in cultured peripheral human lymphocytes. Project no. 340741. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002w) Toxicokinetic assessment of FPC-200. Project no. 340829. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002aa) Determination of ready biodegradability: CO2 evolution test (modified sturm test) with FPC-200. Project no. 340774. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002bb) 96-Hour acute toxicity study in carp with FPC-200 (static). Project no. 340752. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002cc) Acute toxicity study in Daphnia magna with FPC-200 (static). Project no. 340763. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002dd) Fresh water algal growth inhibition test with FPC-200. Project no. 340785. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).

Notox (2002ee) Activated sludge respiration inhibition test with FPC-200 (contact time: 30 minutes). Project no. 340796. Hertogenbosch, Netherlands, Notox Safety & Environmental Research B.V. (unpublished report submitted by the notifier).


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